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Learn from FDA Warning Letters what inspectors look for and what
mistakes other companies make so you can avoid them

Labcompliance On-line Audio Seminar

This seminar has been recorded and is available on CD and for
instant download. All reference material as listed below and more is
available on a special seminar website. The website is regularly
updated with most recent information. In case there are questions
related to the topic, they can be submitted through a web form and
will be answered by the speaker. For ordering info
click here.

On-line Audio Seminar 102

Using Excel® in Part11/GxP Regulated
Environments

Recorded

Spreadsheets like Excel® are frequently used in regulated laboratories and
production environment. Some companies have thousands of them. They need to be
validated and comply with 21 CFR Part 11 and other regulations. The question is
how, because Excel was not designed for part 11 and 'out of the box' Excel does
not have all the functions as required by part 11. And spreadsheets applications
are readily available, easy to program, and easy to change.

Questions are:

What is it we should validate?

I have been using these spreadsheets since years, I know
that they work, why should I start to validate?

Should we test standard Excel functions?

Standard Excel does not have part11 compliant audit trail,
what to do?

Everybody can easily access Excel applications, how to
ensure data security and integrity?

How to prevent that somebody changes the Excel spreadsheet?

How does the audio seminar help:

Solutions will be presented by Dr. Ludwig Huber in a new
interactive audio seminar. During the seminar, the speaker will
present strategies and give practical recommendations. After the
seminar, an extensive list of reference material like SOPs,
templates and examples will help immediate and cost effective
implementation.

During the interactive presentation you learn about:

FDA and EU requirements for Excel applications - What do
inspectors asks and what documents should be available

Developing a culture and infrastructure for
Macros&Spreadsheet compliance

Learn how to design and program Excel spreadsheets with
quality and compliance in mind

Validation of Macros and Spreadsheet application during
development, installation and on-going use

How to ensure security and integrity of spreadsheet
applications?

Which (hidden) Excel functions are available to assist
compliance?

And for easy and instant implementation:
download 10+ documents from special seminar website

SOPs: Validation of spreadsheets and other computer
applications, GxP and part11 training

Gap analysis for Macros and Spreadsheet applications

Spreadsheet validation project schedule

Draft article to be published in Biopharm: Using Macros and
Spreadsheets in Regulated Environment

How to order

About audio seminars

Online audio seminars are presented over the
phone. During the live presentation attendees can:

Study the printed slide material

Watch the slides on a computer

Watch the slides on a video screen in a seminar room

Ask questions through email and web form

About Dr. Ludwig Huber

Dr. Ludwig Huber is the editor and author of Labcompliance. He has been
conducting over 300 web and audio or video based seminars since 15 years and and
he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and
Validation around the world. This included seminars, workshops and presentations
for the US FDA, SFDA, KFDA, HSA, ISPE, PDA, PIC/S and several national health
agencies.

Dr. Ludwig Huber
is a frequent presenter at IVT conferences and has been
awarded as the 'Presenter of the Year' out of 170 speakers.
This photo is from IVT's conference on Network Qualification
with Ludwig Huber as plenary speaker.

Dr. Huber has published several books related to validation and
compliance, for example: Validation of Computerized Analytical and
Networked Systems. He was or still is a member of several
committees, e.g., of the GAMP® Special
interest group (SIG) on Laboratory Computers, PDA Part 11 task
force, IVT task force on network infrastructure qualification and
the European Compliance Academy. He frequently visited FDA in
Rockville, VA, and participated in panel discussions with FDA
professionals. For feedback from attendees of seminars and for
other information on Dr. Ludwig Huber,
click here.